FDA approves Mavenclad, new oral drug to treat MS

March 29, 2019
The U.S. Food and Drug Administration approved Mavenclad® (Cladribine) to treat relapsing forms of MS, including relapsing remitting MS and active secondary progressive MS.

Mavenclad is unique among FDA-approved treatments for relapsing MS in that it is an oral medication with a maximum of 20 days of treatment over a two-year period (no more than ten days per year). Following the administration of treatment over those two years, additional courses are not to be administered. Re-treatment with Mavenclad during years three and four may further increase the risk of malignancy. The safety and efficacy of reinitiating Mavenclad more than two years after completing two treatment courses has not been studied.

Because of its safety profile, use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS, and is not recommended for use in patients with clinically isolated syndrome (CIS). The Mavenclad label includes a boxed warning for potential risk of malignancy and risk of teratogenicity. 

In the clinical trial program, 1,976 patients received therapy for a total of 9,509 patient years, of which the mean time on study including follow-up was approximately 4.8 years and 24% of the follow-up was for eight years. MAVENCLAD demonstrated clinical efficacy across key measures of disease activity, such as annualized relapse rate (ARR), disability progression and MRI activity:

  • Patients experienced a 58% relative reduction in the ARR with MAVENCLAD compared to placebo
  • 81% of patients were free of relapses after two years of short-course oral treatment with Mavenclad, compared to 63% of patients who received placebo
  • Patients treated with Mavenclad had a 33% reduction in risk of 3-month confirmed disability progression as measured by Expanded Disability Status Scale (EDSS) compared to placebo
  • Patients taking MAVENCLAD experienced a lower median number of T1-weighted gadolinium-enhanced brain lesions and new or enlarging T2 brain lesions compared to patients with placebo

The most common (>20%) adverse reactions reported in the pivotal Phase III study, CLARITY, were upper respiratory tract infection, headache and lymphopenia. Serious adverse reactions reported in the clinical program included malignancies (0.27 events per 100 patient-years) in Mavenclad treatment arms, compared to placebo patients (0.13 events per 100 patient-years), and herpes zoster infections (2.0% vs. 0.2%) and oral herpes (2.6% vs. 1.2%). 

MS LifeLines, the support service offered by drug manufacturer EMD Serono, is now expanding to help patients prescribed Mavenclad support, including assistance with navigating insurance questions and additional resources that may be able to assist patients who are uninsured or underinsured. 

For more information on Mavenclad, and prescribing information including the boxed WARNINGS, visit www.MAVENCLAD.com.  

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